Panels › Anesthesiology › Product code CBF · Class 2
Chamber, Hyperbaric
Regulation 868.5470
0510(k)s in 12 months (69 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in CBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Sechrist Industries, Inc. | 5 | 2 |
| Reimers Systems, Inc. | 5 | 0 |
| Environmental Tectonics Corp. | 3 | 0 |
| Gulf Coast Hyperbarics, Inc. | 3 | 0 |
| Pan-America Hyperbarics, Inc. | 3 | 0 |
| Perry Baromedical Corp. | 3 | 0 |
| Perry Baromedical Services | 3 | 0 |
| Fink Engineering Pty, Ltd. | 2 | 0 |
| Hyperbaric Technologies, Inc. | 2 | 0 |
| Hypertec, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 1996 | K951044 | SYSTEM ONE HYPERBARIC CHAMBER Nth Systems, Inc. | CBF |
| Dec 15, 1995 | K954387 | T CLASS HYPERBARIC FACILITIES Reimers Systems, Inc. | CBF |
| Jun 13, 1995 | K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER Sechrist Industries, Inc. | CBF |
| Jun 13, 1995 | K934164 | MODEL 2500E/2500ER HYPERBARIC CHAMBER Sechrist Industries, Inc. | CBF |
| Jun 2, 1995 | K951125 | LIFEFORCE CLINICAL HYPERBARIC FACILITY Reimers Systems, Inc. | CBF |
| Jun 2, 1995 | K950957 | MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM Gulf Coast Hyperbarics, Inc. | CBF |
| Dec 7, 1993 | K933929 | LAB-SITE(R) SAFETY CANNULA Migada, Ltd., IL | CBF |
| Aug 20, 1993 | K930748 | SIGMA MP MULTIPLACE HYPERBARIC CHAMBER Perry Baromedical Services | CBF |
| Jul 22, 1991 | K905168 | HYPERLITE S.O.S. , Ltd., GB | CBF |
| Feb 2, 1988 | K874752 | GAMOW HYPERBARIC BAG Hyperbaric Aerobics, Ltd. | CBF |
| Dec 7, 1987 | K874107 | H.T.U. (HYPERBARIC THERAPY UNIT) Hyox Systems C/O Mechidyne Systems, Inc. | CBF |
| Nov 12, 1986 | K862198 | SIGMA II - DUAL PLACE HYPERBARIC CHAMBER Perry Baromedical Services | CBF |
| May 21, 1986 | K861315 | HYPERBARIC PENETRATION EXTENSION SET Cutter Laboratories, Inc. | CBF |
| Mar 12, 1985 | K850563 | SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION Nautilus Environmedical Systems, Inc. | CBF |
| Oct 12, 1984 | K842303 | MICROSPAN -PH MONITOR Biochem International, Inc. | CBF |
| Aug 7, 1984 | K840841 | RENEAU UNIT Reneau, Inc. | CBF |
| May 2, 1984 | K841608 | MODEL 3000 HYPERBARIC CHAMBER Custom Craft Products, Inc. | CBF |
| Aug 12, 1983 | K832127 | NAUTILUS MONOPLACE HYPERBARIC UNIT Nautilus Environmedical Systems, Inc. | CBF |
| Jul 30, 1979 | K790693 | HYPERBARIC OXYGEN CHAMBER Hyperbaric Oxygen Therapy, Inc. | CBF |
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